CLE-100 as an Oral Therapy in Addition to Standard Antidepressant Drug for Major Depressive Disorder - CLEO Study

  • STATUS
    Recruiting
  • End date
    Jul 31, 2022
  • participants needed
    137
  • sponsor
    Clexio Biosciences Ltd.
Updated on 7 September 2021
Investigator
Clinical Operations Lead
Primary Contact
Clinical Site 111 (0.6 mi away) Contact
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Summary

The clinical trial is a Phase 2, double-blind, randomized, placebo controlled study in Major Depressive Disorder (MDD) participants currently treated with antidepressant therapy. The objective of the study is to assess CLE-100 for the treatment of MDD in participants currently treated with standard antidepressant therapy.

Description

CLEO study is performed in two parts (part A and Part B). The sponsor is currently recruiting only for the Part B of the study.

Part A will be an inpatient study to assess the safety, tolerability, and pharmacokinetics of CLE-100 in MDD participants currently treated with an antidepressant drug. It will include a screening phase (up to 35 days), a 1 week inpatient double-blind treatment phase and an outpatient post treatment safety follow-up phase of 1 week after last study drug administration.

Part B will be a study to assess the safety and efficacy of CLE-100 in MDD participants currently treated with an antidepressant drug with inadequate response to standard antidepressant therapy.

The participants will remain on their current antidepressant therapy with no dose change during the study.

Details
Condition Adjunctive Treatment of Major Depressive Disorder
Treatment Placebo, CLE-100
Clinical Study IdentifierNCT04103892
SponsorClexio Biosciences Ltd.
Last Modified on7 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female between 18 to 60 years of age
Primary diagnosis of MDD without psychotic features according to DSM-5 and supported by the Mini International Neuropsychiatric Interview (MINI)
MADRS score of at least 24 at Screening
At least 2 inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
Current MDE for at least 12 weeks
BMI between 18 and 40 kg/m2, inclusive
Is able and competent to read and sign the ICF

Exclusion Criteria

Inadequate response to more than 5 treatment courses of antidepressant medication therapy during the current MDE
Current MDE for longer than 5 years
Has a lifetime history of any substance use disorder per DSM-5 criteria, except for tobacco use disorder
Has a history or current diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorders
Has a current binge eating disorder or history of (binge) eating disorders within 1 year of Screening
Has dementia, delirium, amnesia, or any other significant cognitive disorder
Has posttraumatic stress disorder, obsessive compulsive disorder, or any other mental disorder (including personality disorders)
Has any medical condition for which an increase in blood pressure or intracranial pressure poses a serious risk
Has been randomized in Part A of this study
Is a female of childbearing potential pregnant or breastfeeding
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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